Sep 2021

Cosmetics Regulations in Canada

The Canadian cosmetics market is projected to register a compound annual growth rate (CAGR) of 6.45% between the forecast periods 2020-2025. The value of the cosmetics market is expected to reach around 15.8 billion U.S. dollars in 2021, an increase of almost three billion U.S. dollars from five years previously. The increasing demand for innovative cosmetic products and online access are attributing key factors for market growth in Canada.[1]

Cosmetics sold in Canada are regulated by Health Canada under the cosmetics regulations, which originally came into force under the Food and Drugs Act (FDA) in 1977. The FDA (formally known as an Act respecting Food, Drugs, Cosmetics, and Therapeutic Devices) is enforced by the parliamentary bodies of Canada regarding the production, import, export, and transport of products across the Canadian provinces.[2] The cosmetic regulations under the FDA help cosmetic companies or manufacturers to protect consumers from health risks associated with the use of cosmetic products marketed in Canada.[3]

The most important requirement of the cosmetic regulations in Canada is that cosmetic products sold on the Canadian market are manufactured, prepared, preserved, packed, and stored under sanitary conditions. As required by the regulations, the safety of the cosmetic product is the responsibility of the product manufacturer and when used correctly as described on the labeling and as intended, a cosmetic product must not pose a risk to the consumer’s health and safety. All cosmetic manufacturers are encouraged to adhere to Good Manufacturing Practices (GMP), allowing cosmetic companies to demonstrate their commitment to safeguarding the quality and safety of their finished cosmetic products.

The Canadian FDA considers cosmetics as personal care products and describes cosmetics as substances or a combination of substances, manufactured, sold, or represented for use in cleansing, improving, or altering the complexion, skin, hair, or teeth and includes deodorants and perfumes.[4] This includes cosmetics products that are sold online, in retail stores, used on consumers in the form of a treatment by aestheticians, and artisanal, handmade cosmetics. As in most countries, the classification of the cosmetic product can often depend on the claims made about its performance and function; examples of cosmetic products include make-up, skincare, fragrance, haircare, and manicure products.

The cosmetics regulations within the Canadian FDA regulate the compliance of cosmetic products based on the ingredients, claims, and the product labeling. The regulator monitors cosmetics that are both manufactured and sold within Canada as well as those that are imported, both of which must adhere in full to the Act and regulations. Cosmetic products placed on the Canadian market must comply with the cosmetic regulation as well as the Consumer Packaging and Labeling Act.

Health Canada maintains quite a broad list of restricted or prohibited ingredients that cosmetic products should not contain, can contain only up to a certain maximum concentration, or may contain under certain conditions. In Canada, the restricted or prohibited list of ingredients is referred to as the Cosmetic Ingredient Hotlist. The cosmetic ingredients on this hotlist are either completely banned, or are limited in how they are used, containing only ingredients used intentionally, along with the warnings that have to be displayed about the use of such ingredients.[5] Canadian Cosmetic Regulations currently prohibit or restrict 573 ingredients, which are listed in the Canadian’s Cosmetic Ingredient Hotlist. As a comparison, the EU prohibits or restricts more than 1,700 ingredients. Furthermore, ingredients in Canadian cosmetic products must be included on the Domestic Substance List (DSL). Innovative cosmetic ingredients that are new to Canada and not a part of the DSL must be notified by cosmetic companies and manufacturers through a New Substance Notification form .

The labeling of cosmetic products in Canada is governed by two Acts and their associated regulations: the FDA/Cosmetic Regulations, the Consumer Packaging and Labeling Act and the Consumer Packaging and Labeling Regulations.[6] Though each Act and regulation has its own approach and process to follow, the Cosmetic Regulations in Canada under the FDA requires all cosmetic product labels to be clearly labeled and to distinctly list all of the ingredients included in the cosmetic product. The label must be clear and consistent, adhere to the established standards and convey to the consumer any potential health risks.[7] Additionally, the cosmetic product labels are required to be in English and French, except for the International Nomenclature of Cosmetic Ingredients (INCI) ingredient names. According to Canadian cosmetic law the labels must include: [8]

  • Name and address of the manufacturer(s)
  • Identity of the cosmetic product, its name, and function
  • The full list of ingredients by INCI name
  • Product net quantity: in metric units of measure in English and French
  • Listed avoidable hazards, warning, and cautions

Under Health Canada’s Cosmetics Regulations, the Canadian regulatory body reserves the right to conduct regular inspections of cosmetic products sold in Canada to ensure they remain compliant. Also, all cosmetic products imported from abroad into Canada are subject to inspection upon notification of intent to sell within the Canadian market.[9] The manufacturer of the cosmetic product must allow its product, ingredients, and procedures surrounding its production to be reviewed to determine compliance with Canadian regulations.

While there is no pre-market registration for cosmetics in Canada, or a notification process as extensive as the European Unions (EUs) cosmetic products notification portal (CPNP) system, all cosmetic products placed on the Canadian market, whether manufactured in Canada or abroad, must be notified to Health Canada. This can be prepared and submitted by a cosmetic product manufacturer, a Canadian importer, or a notifier, who acts on behalf of a manufacturer or Canadian importer, using an online portal known as the Cosmetic Notification Form (CNF).[10] The cosmetic company or manufacturer is essentially responsible for product safety and has to ensure that the product complies with the Cosmetic Regulations in Canada, before being placed on the Canadian market for sale.

As per Cosmetic Regulations, the CNF must be submitted within 10 days of being placed on the Canadian market. The information that needs to be provided on the CNF includes:

  • The address and contact information of the manufacturer(s), importer(s), distributor(s), and formulator(s)
  • The function of the cosmetic product
  • The category of the cosmetic product (for example, moisturizer)
  • The full ingredient list of the cosmetic product
  • The concentration of each ingredient used within the product formulation.

Whenever a change affecting the information that has previously been notified on a CNF is made, it is important for the cosmetic companies, manufacturers, or importers to amend the CNF and resubmit the changes to the CNF to Health Canada.[11] Some examples of changes include; a product name change, or if there is a discontinuation of the sale of that cosmetic product on the Canadian market, or the cosmetic company details have changed (name, address, or contact information of notifier), and if there is a modification to the formulation of the product.

The notification of a cosmetic product does not necessarily mean that the product is automatically approved by Health Canada and is deemed that the cosmetic product complies with all the requirements of the Canadian Cosmetic Regulations.[12]

[1] Cosmetics industry in Canada - statistics & facts

[2] What is a cosmetic?

[3] Frequently Asked Questions - Cosmetic Regulations

[4] Regulatory information for cosmetics

[5] Canada Cosmetic Regulations and Registration CNF

[6] How to register your cosmetic products in Canada

[7] Canada Cosmetic Regulations and Registration CNF

[8] Canada Cosmetic Regulations and Registration CNF

[9] How to register your cosmetic products in Canada

[10] How to register your cosmetic products in Canada

[11] Regulatory information for cosmetics

[12] Regulatory information for cosmetics

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